MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty (MIS GEN II)

May 22, 2014 updated by: Smith & Nephew Orthopaedics AG

A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty

Overall study design:

A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:

  1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
  2. Assess whether there are any differences between the surgical techniques as regards complication rate.
  3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
  4. Assess the x-ray mechanical alignment between the two techniques.

Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.

The primary objectives (mid-term follow-up) of the study are to:

  1. Improvement in Pain and Function per Knee Society Scoring system
  2. Number and Extent of Radiographic Lucencies >2mm
  3. Revision and knee-related adverse events
  4. Improvement in Quality-of-life via the VAS score

5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • Orthopaedic Department, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.

Exclusion Criteria:

  • inefficient femoral or tibial bone stock; BMI >35; fixed flexion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditions that would compromise the 2 years follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimal Invasive Surgery,
Procedure: surgical technique
Active Comparator: Standard Surgical Technique
Procedure: surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew Orthopaedics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIS_GEN_II_6112003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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